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| ID | Type | Description | Link |
|---|---|---|---|
| I9O-MC-AABC | Other Identifier | Eli Lilly and Company | |
| 2018-000773-68 | EudraCT Number |
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The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug").
The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Placebo | Placebo Comparator | Placebo administered subcutaneously (SC) |
|
| Part A: LY3074828 | Experimental | LY3074828 administered SC |
|
| Part B: Placebo | Placebo Comparator | Placebo administered SC |
|
| Part B: LY3074828 | Experimental | LY3074828 administered SC |
|
| Part B: LY900021 | Experimental | LY900021 (LY3074828 + LY9999QS) administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3074828 | Drug | Administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score | The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain). | Within 1-minute post injection |
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Inclusion Criteria:
- Have venous access sufficient to allow for blood sampling and administration of investigational product
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Ltd | Leeds | West Yorkshire | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Placebo |
| Drug |
Administered SC |
|
| LY900021 | Drug | Administered SC |
|